Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
TRUST
Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial
1 other identifier
interventional
150
1 country
5
Brief Summary
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
May 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
July 23, 2026
July 1, 2026
1.1 years
July 25, 2025
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Residual Stone Volume (RSV)
30-Day
Study Arms (2)
Standard Ureteroscopy (URS)
ACTIVE COMPARATORThis is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.
Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System
ACTIVE COMPARATORThe CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Interventions
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.
Eligibility Criteria
You may qualify if:
- Candidate for ureteroscopy with laser lithotripsy
- Be willing and able to return for and respond to all study-related follow up procedures
- Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)
You may not qualify if:
- Untreated urinary tract infection at the time of the index procedure
- Significant comorbidities
- Bladder, ureteral or kidney abnormalities
- Pregnant individuals
- Unable to meet the treatment and follow up protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Calyxo, Inc.lead
Study Sites (5)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Florida
Gainesville, Florida, 32611, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
The University of Texas at Austin, Dell Medical School
Austin, Texas, 78712, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2025
First Posted
August 3, 2025
Study Start
May 21, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2029
Last Updated
July 23, 2026
Record last verified: 2026-07